Process Validation Batches. Lonza shall manufacture and deliver Process Validation Batches as mutually agreed by Parties sufficient to document the operability and reproducibility of the Manufacturing Process and permit the Parties to complete and file the necessary regulatory documents.
Appears in 4 contracts
Sources: Assigned Capacity and Manufacturing Agreement (Forty Seven, Inc.), Assigned Capacity and Manufacturing Agreement (Forty Seven, Inc.), Assigned Capacity and Manufacturing Agreement (Forty Seven, Inc.)
Process Validation Batches. Lonza shall manufacture and deliver Process Validation Batches as necessary as mutually agreed by Parties sufficient to document the operability and reproducibility of the Manufacturing Process and permit the Parties to complete and file the necessary regulatory documentsdocuments for regulatory approval of the Facility and the Facility’s use by Lonza to manufacture Product.
Appears in 1 contract
Sources: Manufacturing Services Agreement (Aurinia Pharmaceuticals Inc.)